Country Approval Specialist - FSP - Italy

Work Schedule

Environmental Conditions

Job Description

Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you’ll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy. As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals.

What You’ll Do:

OBJECTIVES/PURPOSE

• Supporting the facilitation of site start up and communication with internal and external team members to ensure prompt site approval and study timelines are achieved.
• Support sites and study teams to achieve rapid site start up.

ACCOUNTABILITIES

• Work directly with assigned sites on all site related essential document collection and review.
• Partner with internal Study Startup team, CROs, Clinical Operations teams, and partners to improve overall SSU metrics and deliver processes.
• Ensure standards are applied to the SSU processes across projects.
• Review site essential documents for start up including but not limited to: ICF, FDF, 1572, CVs etc
• Promptly recognize and improve potential site activation delays and escalate to appropriate team members.
• Track all actions and communications with sites to ensure timelines are achieved for studies and sites assigned.
• Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team.
• Review and provide feedback to management on site performance metrics.
• Ensure accuracy and completeness of the eTMF for assigned sites during start up

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Understanding of the pharmaceutical industry (e.g., clinical development, the prescription drug distribution process, etc.)
• Understanding of Clinical Trial Agreements, budgeting and fair market value principals
• Knowledge or FDA and ICH-GCP guidelines for conducting clinical research

Leadership

• Demonstrated ability to work across functions, regions and cultures
• The ability to inspire, motivate and drive results
• Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
• Proven skills as an effective team player who can engender credibility and confidence within and outside the company
• Ability to distil complex issues and ideas down to simple comprehensible terms
• Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization

Decision-making and Autonomy

• Broad decision-making responsibilities:
  • Ability to make decisions
  • Accountable for decision making for designated tasks
  • Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
  • Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution 

Interaction

• Effectively navigates the changing external and internal environment
• Effectively represent Takeda in High-level negotiations with the ability to resolve conflict in a constructive manner
• Takes the initiative and proactively resolves challenges with internal and external team members.

Complexity

• Ability to work in a global ecosystem (internal and external) with a high degree of complexity

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• BS degree or international equivalent
• 2 or more years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor.
• Ability to explain data to facilitate decision making processes to be data driven.
• Knowledge and understanding of clinical study protocols and essential documents
• Strong organizational skills, decision making, communication and negotiation skills
• Proficient in Microsoft Excel, Word, and PowerPoint.